MEDDEV 2.7.1 Evaluation of clinical data: A guide for manufacturers and notified bodies;

Annex X of the DIRECTIVE 93/42/EEC of 14 June 1993 “Concerning medical devices”.

2. Description of the product, its functions and characteristics, connected to its clinical use.

2.1. Purpose description

“cem tech” EHF-IR therapy portable device with changeable oscillators (further – the device, changeable therapeutic oscillators), is a source of low-intense and background radiation (less than 10 microWatt/m2) of electromagnetic waves of extremely high frequency (EHF) and light infrared (IR) ranges, non-invasively influencing biologically active points of a body and sites of tissue with a purpose of correction of organs’ and body systems’ functional activity by stimulation processes in tissue.

The device and changeable therapeutic oscillators can be used in treatment-and-prophylactic establishments of different specialization types, as well as individually by prescription of a physician on stationary and outpatient basis.

The device is portable, with internal power supply of the direct current with nominal tension of 3 V (from 2 elements AA, LR03, 1.5 V each).

2.2. Product’s specification

The device consists of portable control unit (PCU) and remote EHF emitters attachable to the device through the connector with flexible cable.

Development of the device was done with consideration of well-known analogous EHF-therapy devices, such as “Yav” and “Amfit”, based on which, large number of clinical estimations was fulfilled. Technical characteristics of “CEM-TECH” allow its use not only as broadband radiation source, but also for working on fixed frequency. The device is made with the use of original technical solution: EHF radiator’s power supply comes from impulses of triangular shape with distinctive features of its resonator. When supplying the impulse on oscillator and its achievement of threshold voltage, the excitation of Gunn diode in broadband mode occurs, than it’s characteristics correspond to radiation of broadband EHF-therapy devices (for example, “Amfit”). With the increase in tension, formation of radiation happens on the diode on fixed generation frequency, which parameters, with appropriate tuning, are comparable to radiation from “Yav” devices.

Thus, technical solutions, executed in EHF-IR therapy device«СЕМ®-ТЕСН», allow its effective work in all modes that are stated in the Owner’s manual.

The device is equipped with several oscillators of different frequency characteristics. Oscillators №1, 2, 3 generate broadband spectrum and have base radiation, that is in a shorter range, while oscillator №4 provides broadband radiation. Sort of oscillator makes a difference when working in active EHF-mode. In BRR-mode, all oscillators, except for infrared, work in the same mode.

The sequence of therapeutic procedures conductance as well as service conditions are described in the Passport, Owner’s manual, and Service manual.

3. Results from risk analysis

3.1 Identified risks

For determination of risks, connected with the use of the device, risk analysis has been carried out in accordance with ISO14971. The results are presented in Risk Management Journal №1/07.

3.1.1 Regarding clinical use

From the risk analysis, according to ISO14971 standards, risks connected to human element using the device and risks connected with unqualified personnel using of the device were revealed, “Risk Management Journal №1/07”. Risks after the conducted activities, can be applied to the category of insignificant and belong to the area of admissible values.

3.1.2 Regarding the chosen technical solution

The chosen technical solution can lead to the risks connected with hygiene, possible undesirable physiologic effect on operator or service stuff, “Risk Management Journal №1/07”. After conducted activities on risk minimization, risks transferred to the area of admissible values.

3.1.3 Regarding the design

Regarding the design, no risks were found.

3.2 Benefit from the device

From the analysis of publications on clinical tests of «СЕМ®-ТЕСН» device, we can conclude that the influence of EHF-radiation on the body helps to:

— reduce pain syndrome of any genesis and inflammatory effects in pathologic centers;

— shorten the period of in-patient treatment for broad list of diseases;

— widen possibilities of rehabilitation treatment in ambulatory and home conditions;

— execute initial and secondary prophylactics.

All researchers certify good tolerance of EHF-influence and the absence of complications and side effects, including in patients that were observed after treatment over long periods of time (1-2 years). Patients had no or slight pain sensations in the place of influence (some patients had sensation of “light pricking” and “goose skin”).

No serious contraindications to the use of the device have been found, however, the prescription of EHF-therapy should be avoided in the following cases:

— Unstated diagnosis;

— Individual intolerance to this type of therapy;

— Pregnancy, because it was not studied;

— Presence of implanted devices with autonomic power supply, for example, artificial pacemaker;

The analysis of possible risks and their compartment with the results of longstanding clinical practice of the devices use for different health disturbances testifies the benefit of the device.

3.3 Comparison of the benefit and residual risk

Considering the fact, declared by the manufacturer, on safety and non-invasiveness of the method, an also, basing on clinical approbation, researchers came to the conclusion that the benefit from the device is bigger than residual risk from its use (Risk Management Journal №1/07, Statement on acceptability of residual risk from 29.05.07).

4. Procedure of working with literature

4.1 Description of the ways of significant literature data obtaining, selection, comparison testing, and critical analysis, used for clinical estimation.

The review includes publications that describe prospective controlled EHF-therapy testing for different diseases, in which analyzed groups of patients were selected by randomization and minimization methods and were comparable in age, sex, heaviness and duration of disease, and presence of concomitant diseases. The results were adequately statistically evaluated.

Selection criteria were met by clinical studies that were done on more than 8000 patients and healthy volunteers in large medical centers in Moscow, Tomsk, Nizhniy Novgorod, and other cities.

EHF-therapy effectiveness was estimated. Therapy was done separately, or together with standard therapy in comparison with standard therapy. Influencing with electromagnetic radiation of EHF-diapason was done on the projection of affected organs or on the pathologic center and/or biologically active points and zones. In the control groups, EHF-therapy was not conducted, or imitation of EHF-therapy was done, that is blind placebo control. In all cases, with the exception of specially pointed out ones, EHF therapy was done in “noise” mode. In the listed studies, the following EHF-therapy devices were used:

“AMFIT” is a production of LLC “FizTech”, Nizhniy Novgorod. The device is approved for use in medical practice on territory of Russian Federation by the order of Russian Ministry of Health form 20.07.1998., it was added to the State Register of Medical Products (Registration Certificate MH RF №29/06030497/2014-01 from 15.06.2001). Sanitary-and-epidemiologic certificate № 77.99.04.944.D.003333.06.01 from 19.06.2001. SSES RF. Broadband noise mode of EHF-therapy is used in the device.

“YAV” is the development of SPO “Istok”, Fryasino under the supervision of N. Devyatkov, Academic of Russian Academy of Science, N.Golant, Professor, D.P-M.S., O.Betskiy (Institute of Radiotechnics and electronic RF RAS). Production is in PO “START”. MinSvyaz Certificate RF № ОС/1-РРС-36. Mode of fixed EHF-therapy frequencies was used in the device.

“STELLA” is the previous name of “CEM-TECH”. Certificate № 99-03-000436 from February 28, 2006. The device is certificated by State-standard of RF (№ РОСС RU.АЯ79.В04381). It is approved for use in medical practice on the territory of Russian Federation, by Committee of new medical appliances of Ministry of Health RF, Extract from the protocol №6 of devices and appliances, used in physiotherapy from 28.06.1995.

Frequency diapasons and power characteristics of mentioned devices are fully identical to the broadband influence modes and influence with fixed frequencies of “CEM-TECH” device.